Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about your child receiving
this vaccine, speak to your doctor or pharmacist.
1. Why is my child receiving Hexaxim?
Hexaxim contains the active ingredients diphtheria, tetanus, pertussis (acellular,
component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus influenzae
type b conjugate vaccine (adsorbed). Hexaxim is a vaccine used to help protect your
child against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and serious
diseases caused by Haemophilus influenzae type b.
2. What should I know before my child receives Hexaxim?
Your child should not receive Hexaxim if they have ever had an allergic reaction to
Hexaxim or any of the ingredients listed at the end of the CMI.
Talk to your doctor your child has any other medical conditions or takes any other
medicines.
3. What if my child is taking other medicines?
Some medicines may interfere with Hexaxim and affect how it works.
4. How does my child receive Hexaxim?
Hexaxim is injected into the muscle in the upper part of your child’s leg or upper
arm, by a doctor or nurse.
Your child will receive two injections given at an interval of at least eight weeks
apart, or three injections given at an interval of at least four weeks apart. This
vaccine should be used according to the local vaccination program.
5. What should I know after my child receives Hexaxim?
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Things you should do
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Keep an updated record of your child's vaccination history.
Attend any appointments made by your doctor or nurse.
Report any side effects to your doctor.
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Looking after your medicine
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Hexaxim is usually stored in the doctor’s surgery or clinic. However, if you need
to store Hexaxim keep it in its original packaging in the refrigerator, between 2°C
and 8°C. Do not freeze Hexaxim.
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6. Are there any side effects?
The most common side effects of Hexaxim are pain, redness or swelling at the injection
site, loss of appetite, crying, sleepiness, vomiting, irritability, fever (temperature
38°C or higher), abnormal crying (prolonged crying), diarrhoea and injection site
hardness.
Serious side effects can include episodes when your child goes into a shock-like state
or is pale, floppy and unresponsive for a period of time (hypotonic reactions or hypotonic
hyporesponsive episodes HHE), serious allergic reaction (anaphylactic reaction) and
fits (convulsions) with or without fever.
Active ingredients:
acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus
influenzae type b conjugate vaccine (adsorbed)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about receiving Hexaxim. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about your child receiving Hexaxim.
Where to find information in this leaflet:
1. Why is my child receiving Hexaxim?
Hexaxim contains the active ingredients diphtheria, tetanus, pertussis (acellular,
component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus influenzae
type b conjugate vaccine (adsorbed). Hexaxim is a vaccine used to protect against infectious diseases.
Hexaxim is used to help protect infants against diptheria, tetanus, pertussis, hepatitis
B, poliomyelitis and serious diseases caused by haemophilus influenzae type b. Hexaxim can be given to children from six weeks of age.
The vaccine works by causing the body to produce its own protection (antibodies) against
the bacteria and viruses that cause these different infections:
Diphtheria is an infectious disease that usually first affects the throat. In the
throat, the infection causes pain and swelling which can lead to suffocation. The
bacteria that cause the disease also make a toxin (poison) that can damage the heart,
kidneys and nerves.
Tetanus (often called lock jaw) is usually caused by the tetanus bacteria entering
a deep wound. The bacteria make a toxin (poison) that causes spasms of the muscles,
leading to inability to breathe and the possibility of suffocation.
Pertussis (often called whooping cough) is a highly infectious illness that affects
the airways. It causes severe coughing that may lead to problems with breathing. The
coughing often has a “whooping” sound. The cough may last for one to two months or
longer. Whooping cough can also cause ear infections, chest infections (bronchitis)
which may last a long time, lung infections (pneumonia), fits, brain damage and even
death.
Hepatitis B is caused by the hepatitis B virus. It causes the liver to become swollen
(inflamed). In some people, the virus can stay in the body for a long time, and can
eventually lead to serious liver problems, including liver cancer
Poliomyelitis (often just called polio) is caused by viruses that affect the nerves.
It can lead to paralysis or muscle weakness most commonly of the legs. Paralysis of
the muscles that control breathing and swallowing can be fatal.
Haemophilus influenzae type b infections (often just called Hib) are serious bacterial
infections and can cause meningitis (inflammation of the outer covering of the brain),
which can lead to brain damage, deafness, epilepsy, or partial blindness. Infection
can also cause inflammation and swelling of the throat, leading to difficulties in
swallowing and breathing, and infection can affect other parts of the body such as
the blood, lungs, skin, bones, and joints.
Important information about the protection provided
Hexaxim will only help to prevent these diseases if they are caused by the bacteria
or viruses targeted by the vaccine. Your child could get diseases with similar symptoms
if they are caused by other bacteria or viruses.
The vaccine does not contain any live bacteria or viruses and it cannot cause any
of the infectious diseases against which it protects.
This vaccine does not protect against infections caused by other types of Haemophilus
influenzae nor against meningitis due to other micro-organisms.
Hexaxim will not protect against hepatitis infection caused by other agents such as
hepatitis A, hepatitis C and hepatitis E.
Because symptoms of hepatitis B take a long time to develop, it is possible for unrecognised
hepatitis B infection to be present at the time of vaccination. The vaccine may not
prevent hepatitis B infection in such cases.
Remember that no vaccine can provide complete, lifelong protection in all people who
are vaccinated
2. What should I know before my child receives Hexaxim?
Warnings
Your child should not receive Hexaxim if:
they have had a previous allergic reaction to Hexaxim, or any of the ingredients listed
at the end of this leaflet.
Always check the ingredients to make sure you can use this medicine.
has had respiratory disorder or swelling of the face (anaphylactic reaction) after
administration of Hexaxim
has had an allergic reaction to any other diphtheria, tetanus, pertussis, poliomyelitis,
hepatitis B or Hib containing vaccines
suffered from a severe reaction affecting the brain (encephalopathy) within 7 days
of a prior dose of a pertussis vaccine (acellular or whole cell pertussis).
has an uncontrolled condition or severe illness affecting the brain and nervous system
(uncontrolled neurologic disorder) or uncontrolled epilepsy
Check with your doctor if your child:
have any other medical conditions
has a moderate or high temperature or an acute illness (e.g. fever, sore throat, cough,
cold or flu). Vaccination with Hexaxim may need to be delayed until your child is
better
has had any of the following events after receiving a pertussis vaccine, as the decision
to give further doses of pertussis containing vaccine will need to be carefully considered:
fever of 40°C or above within 48 hours not due to another identifiable cause.
collapse or shock-like state with hypotonic-hyporesponsive episode (drop in energy)
within 48 hours of vaccination.
persistent, inconsolable crying lasting 3 hours or more, occurring within 48 hours
of vaccination.
fits (convulsions) with or without fever, occurring within 3 days of vaccination.
previously had Guillain-Barre syndrome (temporary inflammation of nerves causing pain,
paralysis and sensitivity disorders) or brachial neuritis (severe pain and decreased
mobility of arm and shoulder) after being given a vaccine containing tetanus toxoid
(an inactivated form of tetanus toxin). In this case, the decision to give any further
vaccine containing tetanus toxoid should be evaluated by your doctor.
is having a treatment that suppresses her/his immune system (the body’s natural defences)
or has any disease that causes the weakness of the immune system. In these cases the
immune response to the vaccine may be decreased. It is normally recommended to wait
until the end of the treatment or disease before vaccinating. However children with
long standing problems with their immune system such as HIV infection (AIDS) may still
be given Hexaxim but the protection may not be as good as in children whose immune
system is healthy.
is born prematurely. Lower responses to the vaccine may be observed in relation with
immaturity of the immune system. However, according to national recommendations, vaccination
should not be delayed. In addition, longer gaps than normal between breaths may occur
for 2 -3 days after vaccination.
suffers from an acute or chronic illness including chronic renal insufficiency or
failure (inability of the kidneys to work properly).
suffers from any undiagnosed illness of the brain or epilepsy which is not controlled.
Your doctor will assess the potential benefit offered by vaccination.
has any problems with the blood that cause easy bruising or bleeding for a long time
after minor cuts. Your doctor will advise you whether your child should have Hexaxim.
has fainted when having a previous injection. Fainting can occur before or following
needle injection.
take any medicines for any other condition
During treatment, your child may be at risk of developing certain side effects. It
is important you understand these risks and how to monitor for them. See additional
information under Section
6. Are there any side effects?
3. What if my child is taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Hexaxim and affect how it works.
Having other vaccines
Your doctor will advise you if Hexaxim is to be given with another vaccine.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Hexaxim.
4. How does my child receive Hexaxim?
How is Hexaxim given
Hexaxim is administered to your child by your doctor or nurse
Hexaxim is injected into the muscle in the upper part of your child’s leg or upper
arm
When is Hexaxim given
First course of vaccination (primary vaccination)
Your child will receive two injections given at an interval of at least eight weeks
apart, or three injections given at an interval of at least four weeks apart.
This vaccine should be used according to the local vaccination programme.
Additional injections (booster)
After the first course of injections, your child may require a booster dose, in accordance
with local recommendations.
Your doctor will advise you if your child requires a booster dose.
If you forget to use Hexaxim
If your child misses a scheduled injection, it is important that you discuss with
your doctor or nurse who will decide when to give the missed dose.
It is important to follow the instructions from the doctor or nurse so that your child
completes the course of injections. If not, your child may not be fully protected
against the diseases.
If you have any further questions on the use of this vaccine, ask your doctor, pharmacist
or nurse.
If you use too much Hexaxim
Overdose is unlikely as your doctor is giving you the injection.
If you have any concerns, ask your doctor or nurse.
5. What should I know after my child receives Hexaxim?
Things you should do
Keep an updated record of your child's vaccination history.
Attend any appointments made by your doctor or nurse.
Report any side effects to your doctor.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
Hexaxim is usually stored in the doctor’s surgery or clinic, or at the pharmacy. However,
if you need to store Hexaxim:
Keep out of reach and sight of children.
Keep Hexaxim in the original pack until it is time for it to be given.
Keep it in the refrigerator, store at 2°C to 8°C. Do not freeze Hexaxim.
Do not use Hexaxim if the packaging is torn or shows signs of tampering.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist
how to dispose of medicines no longer required. These measures will help to protect
the environment.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Other side effects not listed above have been reported occasionally with other diphtheria,
tetanus, pertussis, poliomyelitis, hepatitis B or Hib containing vaccines and not
directly with Hexaxim:
temporary inflammation of nerves causing pain, paralysis and sensitivity disorders
(Guillain-Barré syndrome) and severe pain and decreased mobility of arm and shoulder
(brachial neuritis) have been reported after administration of a tetanus containing
vaccine.
inflammation of several nerves causing sensory disorders or weakness of limbs (polyradiculoneuritis),
facial paralysis, visual disturbances, sudden dimming or loss of vision (optic neuritis),
inflammatory disease of brain and spinal cord (central nervous system demyelination,
multiple sclerosis) have been reported after administration of a hepatitis B antigen
containing vaccine.
swelling or inflammation of the brain (encephalopathy/encephalitis).
in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than
normal between breaths may occur for 2 -3 days after vaccination.
swelling of one or both feet and lower limbs which may occur along with bluish discolouration
of the skin, redness, small areas of bleeding under the skin and severe crying following
vaccination with Haemophilus influenzae type b containing vaccines. If this reaction
occurs, it is mainly after first injections and within the first few hours following
vaccination. All symptoms should disappear completely within 24 hours without the
need for treatment.
If your child gets any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems in Australia or to the Medsafe online at https://pophealth.my.site.com/carmreportnz/s/
in New Zealand. By reporting side effects, you can help provide more information on
the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Hexaxim contains
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Active ingredients
(main ingredients)
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At least 20 IU of diphtheria toxoid
At least 40 IU of tetanus toxoid
25 micrograms of pertussis toxoid and 25 micrograms of pertussis filamentous haemagglutinin
10 micrograms of hepatitis B surface antigen
40 D antigen Units of poliovirus Type 1, 8 D antigen Units of poliovirus Type 2, 32
D antigen Units of poliovirus Type 3
12 micrograms of Haemophilus type B polysaccharide conjugated to 22- 36 micrograms
of tetanus protein
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate
mono basic potassium phosphate
trometamol
sucrose
essential amino acids (cystine, tyrosine, arginine hydrochloride, histidine, isoleucine,
leucine, lysine hydrochloride, methionine, phenylalanine, threonine, tryptophan and
valine)
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
The vaccine may contain traces of glutaral, formaldehyde, neomycin, streptomycin and
polymyxin B. The manufacture of this product includes exposure to bovine materials.
No evidence exists that any case of vCJD (considered to be the human form of bovine
spongiform encephalopathy) has resulted from the administration of any vaccine product.
What Hexaxim looks like
Hexaxim is provided as a fully liquid suspension for injection in pre-filled syringe
(0.5 mL).
Hexaxim is available in a pack containing 1 pre-filled syringe with 1 or 2 needles.
Hexaxim is available in a pack containing 10 pre-filled syringes with 10 or 20 needles.
Not all pack sizes may be marketed.
After shaking, the normal appearance of the vaccine is a whitish cloudy suspension.(Aust
R 215536.)
Who distributes Hexaxim
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in June 2025.
hexa-ccdsv8-ccdsv10-cmiv5-23jun25